Delving into the Latest Updates on Imilecleucel-T with Synapse

Overview

Basic Info

Drug Type

Therapeutic vaccine

Synonyms

Imilecleucel-T (USAN), Tovaxin, Tcelna

Target-

Mechanism

Immunostimulants, T lymphocytes stimulants

Therapeutic Areas

NeoplasmsImmune System DiseasesNervous System Diseases+ [2]

Active Indication-

Inactive Indication

Brain atrophyCarcinoma in situ of uterine cervixClinically isolated syndrome+ [3]

Originator Organization

Opexa Therapeutics, Inc.

Active Organization-

Inactive Organization

Opexa Therapeutics, Inc.

Drug Highest PhaseDiscontinuedPhase 2

First Approval Date-

Regulation-

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Dusko Ilic Stem Cell Laboratories, Guy’s Assisted Conception Unit, Division of Women’s Health, King’s College London Faculty of Life Sciences & Medicine, London, UK dusko.ilic@kcl.ac.uk Collaborations, partnerships & alliances Co-development agreement: Merck Serono & Otsuka Merck (Germany; www.merckgroup.com) subsidiary Merck Serono (Germany; www. merckserono.com) has amended its development and license deal with Opexa Therapeutics (TX, USA; www.opexatherapeutics. com) for Tcelna (imilecleucel-T), handing over US$3 million to further support an ongoing trial with the personalized immunotherapy for multiple sclerosis. Merck’s payment will help fund the current Phase IIb clinical study assessing Tcelna for patients with secondary progressive multiple sclerosis, as well as support planning of potential late-stage trials. Under their original 2013 deal, Merck Serono paid Opexa a US$5 million upfront fee for the option to exclusively license Tcelna – a potential first-in-class personalized therapy, which has received USA fast-track designation for the treatment of multiple sclerosis. Merck’s option can be exercised prior to or upon completion of the ongoing midstage study, top-line data from which is expected in the second half of 2016. If this occurs, Merck will pay Opexa another US$25 million (or US$15 million, depending upon whether certain conditions are met) for worldwide development and commercial rights excluding Japan, and fund its further development.

01 Jul 2011·Expert Opinion on Biological TherapyQ3 · MEDICINE

Tovaxin for multiple sclerosis

Q3 · MEDICINE

Review

Author: Rivera, Victor M

INTRODUCTIONA potential therapeutic possibility for multiple sclerosis (MS) is provided by Tovaxin, a personalized autologous T-cell immunotherapy utilizing myelin-reactive lymphocytes from peripheral blood.AREAS COVEREDThis review covers the production of the vaccine, which follows a series of steps after the acquisition of T-cells. This includes identification of the subsets that are myelin reactive, expansion ex vivo and, also extrinsically, inactivation of their replication capacity by cellular irradiation. Once attenuated, the modified cells are reintroduced into the donor. This process appears to induce a vigorous immune response towards specific populations of autoreactive T-cells determined to attack the myelin and its derivatives by trafficking from the vascular space into the CNS in MS. Historical aspects of the T-cell vaccination with Tovaxin, the process to obtain reactive T-cells and their attenuation techniques ex vivo are described. The clinical results obtained from clinical trials are also discussed.EXPERT OPINIONThe process of T-cell vaccination is complicated and presents some limitations. Further studies are required to provide scientific support and clinical evidence of the efficacy of Tovaxin in MS.

01 May 2009·Clinical ImmunologyQ3 · MEDICINE

Autologous attenuated T-cell vaccine (Tovaxin®) dose escalation in multiple sclerosis relapsing–remitting and secondary progressive patients nonresponsive to approved immunomodulatory therapies

Q3 · MEDICINE

Article

Author: S. Inman ; D. Rill ; J.C. Williams ; K. Von Gynz-Rekowski ; B. Loftus ; P. Garces ; M. Montgomery ; J. Zhang ; B. Newsom ; M. Riser

An open-label dose escalation study of T-cell vaccination in multiple sclerosis patients was conducted using attenuated myelin reactive T-cells (MRTC) selected with six myelin peptides, two each from MBP, PLP and MOG. The dose range of subcutaneous injections given at weeks 0, 4, 12 and 20 was 6-9E6, 30-45E6 and 60-90E6 irradiated MRTC. Assessments were over 52 weeks for MRTC levels, EDSS, MSIS-29, brain MRI and relapses. The 30-45E6 dose was the most effective with reductions in MRTC ranging from 92.4% at week 5 to 64.8% at week 52. The reduction in relapses compared to baseline for the M-ITT and evaluable per-protocol analyses were 63.5%, and 85.0% at week 52. The MRI lesions were stable while there was an improvement trend in the EDSS and MSIS-29 physical subscore following the second injection. Adverse events were mild to moderate in intensity with mild injection site reactions occurring with increasing dosage. The mid-dose was selected for further clinical development studies because of the rapid depletion of peripheral blood MRTC and a trend for improvements in clinical outcomes following immunization.

100 Deals associated with Imilecleucel-T

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External Link

KEGG	Wiki	ATC	Drug Bank
D10472	-	-	-

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Brain atrophy	Phase 2	US	Opexa Therapeutics, Inc.	01 Aug 2012
Brain atrophy	Phase 2	CA	Opexa Therapeutics, Inc.	01 Aug 2012
Disease Progression	Phase 2	US	Opexa Therapeutics, Inc.	01 Aug 2012
Disease Progression	Phase 2	CA	Opexa Therapeutics, Inc.	01 Aug 2012
Multiple Sclerosis, Secondary Progressive	Phase 2	CA	Opexa Therapeutics, Inc.	01 Aug 2012
Clinically isolated syndrome	Phase 2	US	Opexa Therapeutics, Inc.	01 Nov 2007
Carcinoma in situ of uterine cervix	Phase 2	US	Opexa Therapeutics, Inc.	01 May 2006
Multiple Sclerosis, Relapsing-Remitting	Phase 2	US	Opexa Therapeutics, Inc.	01 May 2006
Multiple Sclerosis, Secondary Progressive	Phase 1	US	Opexa Therapeutics, Inc.	01 Aug 2012